Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381076
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-19
Brief Title:
Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis n15 to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress Participants will be randomized via a computer-generator into either the control or intervention group Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks At baseline weeks 8 and 12 participants will have blood sampled and complete a 3-day 24-hour recalls 2 non-dialysis days and 1 dialysis day and a quality of life survey
Detailed Description:
This is a 12-week double-blind randomized controlled trial to evaluate the impact of liposomal curcumin in a high-protein product on inflammation markers for adults undergoing hemodialysis CRP and oxidative stress will be assessed from monthly blood samples using Elisa kits Quality of life will be measured using the standard 36-item kidney disease quality of life instrument There will be a 2-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial Eligible participants will sign the consent form to participate in the study Once the expected number of participants has been reached they will be randomized 11 using block randomization Randomization will be done using a computer-generated program
The intervention will take place over an 8-week period Participants will have their blood drawn at the beginning of the study by the dialysis practitioner and start receiving the product on their next scheduled dialysis appointment Participants will be receiving the product three times a week in accordance with their dialysis schedule M-W-F or T-Th-S for a total of 24 treatments Blood will be collected at baseline at the end of the study and a month after to assess any carryover effects Additionally participants will complete 3-day 24-hour recalls 2 non-dialysis days and 1 dialysis day a spice-consumption survey and a quality-of-life assessment at the beginning and end of the study
The intervention will take place over an 8-week period Participants will have their blood drawn at the beginning of the study by the dialysis practitioner and start receiving the product on their next scheduled dialysis appointment Participants will be receiving the product three times a week in accordance with their dialysis schedule M-W-F or T-Th-S for a total of 24 treatments Blood will be collected at baseline at the end of the study and a month after to assess any carryover effects Additionally participants will complete 3-day 24-hour recalls 2 non-dialysis days and 1 dialysis day a spice-consumption survey and a quality-of-life assessment at the beginning and end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None